Colostomy appliance



Aug. 27, 1968 5 HQOPER 3,398,744

COLOSTOMY APPLIANCE Filed June 17, 1965 2 Sheets-Sheet 1 FINGER N/CHE FiEdwin A. Hooper INVENTOR.

BY MM 13m 2 Sheets-Sheet 2 Filed June 17, 1965 r Edwin A. HooperINVENTOR.

United States Patent 3,398,744 COLOSTOMY APPLIANCE Edwin A. Hooper, SaltLake City, Utah, assignor of onethird each to Waldemar A. Wallberg, SaltLake City, Utah, and Melvin J. Clawson, Pacifica, Calif. Filed June 17,1965, Ser. No. 464,659 7 Claims. (Cl. 128-283) ABSTRACT OF THEDISCLOSURE The colostomy appliance disclosed enables the wearer to moveabout unhampered and to participate in and cope with all essentialactivities of life, including certain athletic events previouslyimpossible to engage in when wearing competitive appliances. Thisinnovation is characterized by an adapter unit embodying a bagattaching, suspending and filling neck, an annular pressure responsiveflange carried by and surrounding said neck and lateral to the axis ofsaid neck and capable of residing in intimate contact with the abdomen.The mouth of the bag is gathered tightly around the neck. The lipportions of the bags mouth portion are initially guided by hand andpressed against an exterior channeled surface of said flange. Abag-mouth binding, sealing and retaining unit encircles the mouthportion of the bag and neck. This retaining and capping unit is readilyand manually applicable and removable and equipped with a cleat wherebya body encircling belt can be attached to slotted ends of said cleat.

The present invention relates to certain new and useful improvements ina colostomy appliance to be worn by a person having a colostomy andfunctionally designed and structurally adapted to securely and reliablyhold a commonly used plastic bag which provides for temporary collectionand storage and subsequent disposal of body fluids and human excretareferred to in practice as body waste materials.

Persons conversant with the state of the art to which the inventionrelates are aware that it is common practice to use a plastic bag,usually a flimsy transparent bag such as is purchased from a surgicalsupply house and to attach the bag through the medium of one applianceor another to the users body with the aid of an adapter and an elasticor an equivalent belt which is connected to the adapter and encirclesthe body of the wearer. It has been noted in connection with certainprior art adaptations that no protective means is afforded to preventthe bag from being shut ofl manifestly, a downward pull exerted on thebag, due to the weight of the contents, often shuts off the freeexpelling of gases and fluids from the stoma and, unfortunately,promotes irritation to the stoma and engenders a needless peristolticaction which follows. Then, too, there is usually no guard to preventbruising of the stoma from bumping or from other accidental occurrences.

In carrying out the present invention the construction is such that thelip of the mouth portion of the plastic bag is capable of being heldbetween coacting and oriented surfaces of precision-made plasticcomponents or units which assures no slippage of the bag and virtuallyguarantees the wearer complete mental freedom from the worry andembarrassing experiences that often are encountered.

The appliance is of suflicient size to cover and protect the entirecolostomy. The shape of the part that fits against the abdominal wall issuch as to allow complete freedom of movement to the body and no amountof flexing of the muscles of the body will break the seal of theappliance from the wall and accordingly, it acts to prevent seepage offluids to the surrounding skin area and the clothing.

The invention also has to do with a structurally unique 3,398,744Patented Aug. 27, 1968 ice appliance which is light in weight, yetpractically indestructible and is capable of being cleaned andsterilized with a minimum of time, effort and labor. The applianceincludes an outer unit which affords protection from outside pressuresand accidental bumping which might otherwise injure the stoma and yet atthe same time the raised portion of the neck of the inner unit preventsthe weight of the bag or other pressure from collapsing and closing oitthe free passage of gases and fluids from the stoma into the receptaclepart of the bag and also prevents any irritation to the stoma and theconsequential peristolsis action that follows.

The present invention also features a construction and arrangement oforiented cooperating components or units which are such in constructionthat they do not require special bags but only that they be of such sizeas would be reasonably used and of such material as will hold thecontents without leakage such as present plastic bags are manufacturedfrom. It is within the purview of the concept that the units are suchthat they provide a belt supported innovation which would make it withinthe realm of reason to actually use bags of the plastic type which canbe purchased from grocery stores as 'so-called Baggies and Glad Bags,for example. On the other hand, it should be noted that perhaps thesebags might be very light and not too durable and it is recommended thatthey not be used but instead the bags that are sold by pharmaceuticaland surgical sources are preferable. Nevertheless, the appliance doesprotect the stoma from any irritation and pressure of the bag and itscontents and by its design will hold any size bag or any shape bagwithin reasonable limitations, the bag being clampingly held, that isthe lip portion of the mouth between the two component parts or unitswith no dependence on pressure applied by the wearers belt.

It will be evident as will be hereinafter more fully set forth that theinvention has to do with ways and means whereby simply but carefullymolded component parts or units have coacting surfaces and whichfunction to hold the bag between the surfaces. Particularly it will benoted that there are no prior art appliances known which take intoaccount and afford protection against the weight of the contents of thebag from pulling downward and thus shutting off the free escape of gasesand fluids from the stoma to the bag and the attending difficulties.With my invention the wearer is free to move in any manner so that it ispossible to participate and enjoy normal activities of life and evenengage in many of the athletic activities, including swimming, that havebeen previously impossible to cope with when using presently availableappliances and accessories. Speaking generally the invention ischaracterized by specially molded plastic components or units which areanalogous to inte-rfitting coupling members and which are coupledtogether in such a way that the thus provided two-part unit is worn muchin the same manner as a truss for ruptures is worn. This is to say theinvention is worn similar to a truss which is provided with an elasticor an equivalent belt but is distinctive in that clear plastic colostomybags are capable of being moresatisfactorily and applicably used inconnection therewith.

Briefly but specifically the appliance is characterized by a wastetrapping bag having an intake mouth for communicative alignment with thestoma with which it is oriented when in use, an adapter unit embodying abag filling and holding neck, an annular abdomen abutting flange carriedby and surrounding said neck and lateral to the axis of said neck andcapable of residing an intimate contact with the abdomen and encirclingsaid stoma, the mouth of said bag being gathered and wrapped around saidneck and the marginal and lip portions of the mouth portion beinginitially placed by hand and pressed against an exterior surface of saidflange, and a bag-mouth binding, sealing and retaining unit encirclingthe mouth portion of the bag and said neck, said retaining unit beingreadily and manually applicable and removable and equipped with meanswhereby a body encircling belt can be attached thereto.

More specifically the concept has to do with a colostomy bag attachingand supporting device or appliance which is characterized by an inwardlypositionable unit comprising a bag suspending and filling neck having aninward end provided with an endless annular flange having an inwardlyfacing knurled convex anti-skid surface designed and adapted to abut andbear against that portion of the wearers abdomen encircling theassociated stoma and the neck communicably registering with the stoma,the outwardly facing side of said flange being concave and the concavityproviding a seating and sealing channel for the free edged 'lip portionof the b-ags mouth after the latter has been gathered around the neckand jammed and pressed into the channel; an outwardly positionableretainer unit complemental to said adapter unit and characterized by aring-like collar applicable over and encircling said neck, that edge ofthe collar proximal to said channel being fashioned into a clamping riband the latter projecting and being keyed in said channel, the outwardlydisposed edge of said collar having a partial disklike wall portioncoacting and defining a protective shield, and means thereon forattaching a body encircling belt thereto.

These together with other objects and advantages which will becomesubsequently apparent reside in the details of construction andoperation as more fully hereinafter described and claimed, referencebeing had to the accompanying drawings forming a part hereof, whereinlike numerals refer to like parts throughout, and in which:

FIGURE 1 is a view in perspective showing the improved colostomyappliance and how it is constructed and worn in conjunction with asomewhat conventional type colostomy bag and also a suitable bodyencircling appliance and bag supporting belt;

FIGURE 2 is a section through the appliance or device takenapproximately on the plane of the section line 22 of FIGURE 1 with theview appropriately enlarged;

FIGURE 3 is a section on the horizontal section line 33 of FIGURE 2;

FIGURE 4 is an exploded perspective view wherein all of the componentparts are shown;

FIGURE 5 is an end elevational view of the components assembled but withthe bag and belt removed; and

FIGURE 6 is a view in perspective on a smaller scale which shows thatthe convex abdominal abutment or applicable side of the inwardlydisposed adapter can be and preferably is milled, sand blasted orotherwise knurled to provide a suitable anti-skid or anti-slippingsurface.

With reference to the general in use adaptation as shown for example inFIG. 1 it will be evident that the overall combination includes anappropriate bodyencircling belt 8 for supporting and attaching acolostomy bag 10. It is a mat-ter of common knowledge that bags of thetype shown and herein referred to are common not only in use but in manyprior patents. This is to say the bag is a common flimsy cleartransparent plastic elongated bag whose attachable end portion has aneck 12 (FIG. 4) and an intake mouth 14 which is likewise suitablygathered in use and which may be said to terminate in a laterallybendable and attachable terminal or lip portion 16. As also shown inFIG. 4 one of the primary components or units is the clear plastic unit18. This unit is made up essentially of a cylindrical neck 20 ofappropriate diameter, that is so that the intake end thereof willcoordinate and orient with the stoma in the manner illustrated in FIGS.2 and 3. This neck has a cutaway lower half-portion 22 which definesanoverhanging upper semicylindrical half-portion 24 which serves in amanner to be hereinafter described. The neck has its intake endattachable to the central apertured portion of an annular flange 26.This flange as best shown in FIGS. 2 and 3 is concavo-convex incross-section. This is to say the applicable body contacting convexsurface is denoted at 28 and is applied in the manner illustrated inFIGS. 2 and 3. In actual practice as shown in FIG. 6, this surface willbe milled, knurled, sandblasted or otherwise finished to provide adesirably usable anti-skid finish. The concave outwardly facing sidedenoted at 30 provides an endless channel or groove which encircles theouter peripheral surface of the neck in concentrically spacedrelationship. It will be noted that the overhanging upper half portion24 of the neck projects well beyond the open side of the channel andthat the channel provides a receiver and keyway for the mouth and lipportions 14 and 16 of the attachable suspended bag. The numeral 32designates diametrically opposite red dots or indicating spots whichwill be later mentioned, these being related to the distinguishableupper and lower half-portions 24 and 22 of the neck as perhaps evidentfrom FIG. 4. In any event, the mouth and lip portions of the bag aregathered around or fitted over and around the neck and then seated inthe cavity-like channel or keyway when the invention is being used. Thecomplemental and companion plastic unit 34 is of a diameter conformablewith that of the unit 18. This unit 34 is a cap and a cover as well as aretainer. It is characterized in part by an endless ring-like collar 36which is of the diameter that it can be fitted over the outer peripheralsurfaces of the neck 20. The inner periphery of the collar has a groovetherein as at 38 (FIG. 2) to accommodate a gasket or packing ring 40which effects a satisfactory sealing result. The cross-section of thecollar is such that the end portion to the right in FIG. 2 constitutes arib 42 and projects into the channel to assist in forcibly pressing thelip 16 of the bag between the coacting surfaces to achieve the desiredcoupling of the two units 18 and 34 and the fastening therebetween ofthe mouth portions of the bag 10. It will also be noted that thissection or unit 34 has a substantially semicircular or similar andslightly convex apron-like wall 44 which constitutes a shield-alsoreferred to as a guard. The lower notched and cutaway edge portion ofthis shield denoted at 46 is contoured and elevated and cooperates withthe receding or cutaway lower portion 22 of the neck whereby to thusprovide desired clearance for the attached and suspended neck portionsof the bag as shown with requisite nicety in FIG. 2. The belt attachingmeans comprises a simple plastic, metal or non-corrodible plate 48having end portions 50 slotted at 52 to accommodate the attachable endportions 54 of the aforementioned belt 8. Suitable holes 56 are providedfor headed screwthreaded fasteners 58 which pass through the holes andare secured in sockets 60 in a manner to thus superimpose the plate 48on the guard or shield 44 with the ends projecting to accommodate theattachable ends of the belt.

It will be evident that the size of the appliance will be dependent tosome extent upon the size of the stoma and the colostomy incision.Accordingly, it is not the specific size or materials which aresignificant but rather the construction, design and orientation of thecomponent units 18 and 34. The purpose in showing the bag attached is toemphasize that the attachment can be readily understood and thesimplicity of the attachment can be quickly evaluated.

All presently investigated prior art adaptations depend to a largeextent upon the pressure of the belt of the wearer to hold the bag inplace on the ring or other attaching means which is fitted to the bodyand surrounds the stoma. Novelty is predicated on the herein disclosedappliance which employs the principle of holding the bag between thesurfaces of the component parts or units 18 and 34 particularly betweenthe peripheral surfaces of the neck 20 and inner surface of theencompassing collar 36. Then, too, the clamping action wherein the rib42 presses and seats the lip portion of the bag is important in that asealing result is achieved. Further novelty is predicated upon thecutaway half-portion 22 of the neck 20 wherein the component or upperhalf portion 24 overhangs and coacts with the outwardly spaced interiorof the wall or shield 44 to allow for space and clearance which preventsthe mouth of the bag from being choked or undesirably squeezed.

The unit 34 functioning as a cover is designed for strength anddurability and at the same time to be inconspicuous under the wearersclothing. A bag is placed through the outer bottom outlet 46 and ispulled through the inner side and folded back over the outer edge. Thisprevents the body waste from getting on the coacting half or unit thusallowing it to stay clean and sanitary. The aforementioned dotsindicated at 32 are properly aligned and oriented with the saddle strapor plate 48. The radius is to permit the appliance to conform to theabdominal wall in the most comfortable position for the wearer. The unit18 is designed to let the stoma be free and yet protected from outerpressure. The invention has been constructed and used and it is knownthat it provides a better seal and more securely prevents body fluidsfrom escaping. The crimping and gathering of the lip portion of the bagand the manner in which it is retained 'in conjunction with the O-ringprovides primary and secondary seals which help to compress the plasticbag and increase the holding security. It is believed that these andother features and advantages of the invention will be clearly evidentfrom the description, views of the drawing and the invention as claimed.Accordingly, a more extended description is regarded as unnecessary.

The foreging is considered as illustrative only of the principles of theinvention. Further, since numerous modifications and changes willreadily occur to those skilled in the art, it is not desired to limitthe invention to the exact construction and operation shown anddescribed, and accordingly all suitable modifications and equivalentsmay be resorted to, falling within the scope of the invention asclaimed.

What is claimed as new is as follows:

1. An attaching and supporting appliance for a pliant plastic colostomybag comprising. in combination, an adapter unit comprising a bagsuspending and filling neck having an inward intake end provided with anintegral outstanding encircling annular flange having an inwardlydisposed convex surface designed and adapted to conformingly abut andbear against that portion of the wearers abdomen encircling the stomawith said intake of the neck communicably registering with the stoma,the outwardly facing side of said flange being concave and providing anendless seating and sealing channel for the free edged lip portion ofthe bags mouth after said lip portion has been gathered and snuglywrapped around the neck and conformingly pressed into said channel; andan outwardly positionable bag binding and retainer unit complemental tosaid adapter unit and characterized by a ring-like collar conformable insize to and encircling said neck, the inner edge of the collarconfronting and being proximal to said channel having an endless bagclamping rib conformable in shape to and projecting into and beingremovably keyed in said channel, the outwardly disposed edge of saidcollar having a disk-like wall portion spaced from but spanning thedischarge end of said neck and coacting therewith and defining abagmouth covering shield, and means fixed atop and across said wallportion for attaching a body encircling appliance supporting beltthereto wherein said neck is of a length that the discharge end projectsa predetermined degree beyond the open side of said channel, the lowerhalf-portion of said neck being undercut in a manner that the projectingupper half-portion overhangs and extends beyond the undercutlowerhalf-portion.

2. The structure according to claim 1, and wherein said belt attachingmeans comprises a cleat fixed atop the exterior surface of the wallportion of said retaining unit and provided with projecting slotted endportions designed and adapted for attaching end portions of said belt tosaid cleat.

3. The appliance defined in claim 2, and wherein said convexity radiusof said convex surface is custom-fitted and contoured to minimize beltimposed pressure while at the same time assuring eflicaciousleak-proofing con tact of said convex side with the body areaencompassing the stoma.

4. The structure defined in claim 3, and wherein the over-all surface ofsaid convex surface is knurled to guard against shifting and accidentalslippage of said appliance when in use. a

5. The structure according to claim 1, and wherein a lower marginal edgeportion of said wall portion is cut away to uncover and expose anadjacent portion of the bags mouth portion in a manner to prevent saidportion from being undesirably squeezed or accidently collapsing andchoking off the free delivery and entry of waste fluid and human exretainto the bag by way of said neck.

6. An attaching and supporting appliance for a pliant plastic colostomybag comprising, in combination, a clear plastic adapter unit comprisinga bag suspending and filling neck, said neck being cylindrical andhaving an inwardly disposed intake end provided with an integraloutstanding encircling annular flange having an inwardly facing convexsurface expressly contoured and adapted to conformingly abut and bearagainst that portion of the wearers abdomen encircling the stoma withthe intake of the neck communicably registering with the stoma, theoutwardly facing side of said flange being concave and providing anendless seating and sealing channel for the free edged flexible lipportion of the bags mouth after said lip portion has been gathered andhand-wrapped around the neck and flared and pressed into said channel;and an outwardly positionable retainer unit for said lip portioncomplemental to said adapter unit comprising a ring-like clear plasticcollar encircling said neck, the edge of the collar proximal to saidchannel having a lip portion clamping rib projecting into and beingremovably keyed in said channel, the outwardly disposed edge of saidcollar having a segmental wall portion spanning but spaced outwardlyfrom the discharge end of said neck and coacting therewith and definingan anticollapsing shield, means carried by said wall portion forattaching a body encircling appliance supporting belt thereto, said neckbeing of a length that it projects well beyond the outward marginal edgeof said flange, the lower half-portion of said neck being undercut andthe upper half-portion overhanging the undercut half-portion in a mannerto minimize the possibility of choking off free entry and delivery ofwaste matter into said bag by way of said neck, said shield beingimperforate and substantially semi-circular in plan and having a lowermarginal edge portion notched to provide a clearance opening, saidclearance opening being aligned with said undercut half-portion of saidneck and cooperating with said out back half-portion in a manner toprevent accidental squeezing or in any manner collapsing of or chokingoff the attachable neck portion of the bag.

7. The structure according to claim 6, and wherein said means comprisesa cleat fixed in a horizontal plane atop said shield and provided withprojecting slotted end portions having the function and capability ofattaching end portions of said belt thereto the inner peripheral surfaceof said collar having diametrically opposite marker spots which areoriented with said cleat to facilitate assembling the units incoordinating relationship.

(References on following page) References Cited UNITED STATES PATENTSDiadul 128-283 Van Hove 128283 McConnell 128--283 Carstensen 128283Mason 128-283 Johnson 128283 Mason 128-283 Galindo 128283 Nelsen 128-283CHARLES F. ROSENBAUM, Primary Examiner.

